At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 85 enrolled
Drug / intervention
BIA 9-1067 (clinical micronized, CM) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating BIA 9-1067 (clinical micronized, CM) and BIA 9-1067 (to-be-marketed, TBM) for Parkinson. Completed, enrolled 85 participants.
Detailed Summary
Single-centre, open-label, randomised, three-part, two-way crossover study in 84 healthy volunteers. In each part, the study consisted of two consecutive single-dose treatment periods separated by a washout period of at least 14 days.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMar 2014
Primary CompletionJun 2014
First PostedDec 2014
TodayJul 2026
First PostedDec 2, 2014
Enrollment StartMar 1, 2014
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.6 years ago
Interventions
BIA 9-1067 (clinical micronized, CM)drug
BIA 9-1067 (to-be-marketed, TBM)drug